GLICLAZIDE 60 mg Модифицированные Таблетки

Содержание инструкции

1. Gliclazide Teva 60 mg modified-release tablets
   1. What is Gliclazide Teva and what it is used for
   2. What you need to know before taking Gliclazide Teva
   3. How to take Gliclazide Teva
   4. Possible side effects
   5. How to store Gliclazide Teva
   6. Contents of the pack and other information

Gliclazide Teva 60 mg modified-release tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Gliclazide Teva is and what it is used for
• 2. What you need to know before you take Gliclazide Teva
• 3. How to take Gliclazide Teva
• 4. Possible side effects
• 5. How to store Gliclazide Teva
• 6. Contents of the pack and other information

1. What is Gliclazide Teva and what it is used for

Gliclazide Teva is a medicine that reduces blood sugar levels (oral antidiabetic belonging to the
sulfonylurea class).
Gliclazide Teva is indicated for the treatment of adult patients with a particular form of diabetes
(type 2 diabetes mellitus) when diet, exercise and weight loss alone are not
sufficient to maintain correct blood sugar levels.

2. What you need to know before taking Gliclazide Teva

Do not take Gliclazide Teva

• if you are allergic to gliclazide or to any of the other ingredients of this medicine (listed in section 6), to other medicines of the same class (sulphonylureas) or to other related drugs (sulphonamide hypoglycaemics);
• if you suffer from insulin-dependent diabetes (type 1);
• if ketones and sugars are present in your urine (which may be indicative of diabetic ketoacidosis), or if you suffer from pre-coma or diabetic coma;
• if you suffer from severe kidney or liver diseases;
• if you are taking medicines for the treatment of fungal infections (miconazole; see section “Other medicines and Gliclazide Teva”);
• if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Gliclazide Teva.
To achieve adequate blood sugar levels, it is necessary to follow the treatment plan prescribed
by your doctor, which includes, in addition to regular intake of the tablets, a suitable diet,
a regular and sufficient nutritional intake (with carbohydrates and including breakfast), physical exercise and,
if necessary, weight loss.
During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly also in urine) and, if
necessary, glycated haemoglobin (HbA1c) is required.
During the first few weeks of treatment, the risk of a decrease in blood sugar levels
(hypoglycaemia) may be greater. It is therefore vitally important that you are carefully monitored by
your doctor.
Low blood sugar levels (hypoglycaemia) may occur if:

• you eat irregularly or skip meals altogether;
• you are fasting;
• you are malnourished;
• you make changes to your diet;
• you increase physical activity without adequately increasing carbohydrate intake;
• you drink alcohol, especially in combination with not eating meals;
• you take other medicines or natural remedies at the same time;
• you take excessively high doses of gliclazide;
• you suffer from particular hormonal disorders (functional disorders of the thyroid, pituitary or adrenal cortex);
• your kidney or liver function is severely impaired.

If you suffer from low blood sugar levels, the following symptoms may occur: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggressiveness, decreased concentration, reduced reflexes and reaction time, depression, confusion, speech or vision disorders, tremors, sensory disturbances, dizziness and feeling of weakness.
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, rapid or irregular heartbeat, high blood pressure, severe and sudden chest pain with possible radiation to surrounding areas (angina pectoris).
If blood sugar levels continue to fall, significant confusion (delirium), convulsions, loss of self-control, shortness of breath and decreased heart rate may develop, with possible
loss of consciousness.
In most cases, the symptoms caused by low blood sugar levels disappear very
quickly with the intake of certain types of sugars, such as glucose tablets, sugar lumps, fruit juices or sweetened tea.
For this reason, it is advisable to always carry some sugar with you (glucose tablets, sugar lumps). Remember that artificial sweeteners are not effective. If taking sugar does not provide
any benefit or if symptoms recur, consult your doctor or the nearest hospital.
It is possible that the symptoms caused by low blood sugar levels may not occur, that they are less
evident, that they develop very slowly or that you are unable to notice the decrease in blood sugar in time. This
may affect elderly patients taking certain medicines (e.g. those that act on the
central nervous system and beta-blockers).
If you are in stressful situations (e.g. accidents, surgery, fever, etc.), your doctor may temporarily switch you
to insulin therapy.
The symptoms caused by high blood sugar levels (hyperglycaemia) may occur when the
gliclazide has not yet sufficiently reduced blood glucose, when you have not followed the treatment plan
prescribed by your doctor or in particular stressful situations. They may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections and reduced performance.
If you observe these symptoms, you should contact your doctor or pharmacist.
If you have a family history or are aware of suffering from glucose-6-phosphate dehydrogenase (G6PD) deficiency
(an abnormality of red blood cells; a hereditary condition), a decrease in haemoglobin levels and the breakdown of red blood cells (haemolytic anaemia) may occur.
Contact your doctor or pharmacist before taking Gliclazide Teva.

Children and adolescents
Due to a lack of data, the use of Gliclazide Teva is not recommended in children and adolescents.

Other medicines and Gliclazide Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Taking any of the following medicines may enhance the hypoglycaemic effect exerted by
gliclazide or cause the appearance of signs related to low blood sugar levels:

• other medicines used for the treatment of high blood sugar levels (oral antidiabetics, GLP-1 receptor agonists or insulin);
• antibiotics (e.g. sulphonamides, clarithromycin);
• medicines for the treatment of high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril);
• medicines for the treatment of fungal infections (miconazole, fluconazole);
• medicines for the treatment of ulcers in the stomach or duodenum (H2 receptor antagonists);
• medicines for the treatment of depression (monoamine oxidase inhibitors);
• pain relievers or anti-rheumatic drugs (phenylbutazone, ibuprofen);
• medicines containing alcohol.

The use of any of the following medicines may weaken the blood sugar-lowering effect exerted by gliclazide and increase blood glucose:

• medicines for the treatment of central nervous system disorders (chlorpromazine);
• medicines that reduce inflammation (corticosteroids);
• medicines for the treatment of asthma or used during labour (salbutamol intravenously, ritodrine and terbutaline);
• medicines for the treatment of breast diseases, heavy menstrual bleeding and endometriosis (danazol).

Gliclazide Teva may enhance the effects of anticoagulants (e.g. warfarin).
Consult your doctor before starting to use other medicines. If you are admitted to hospital, tell
the medical staff that you are taking Gliclazide Teva.

Gliclazide Teva with food, beverages and alcohol
Gliclazide Teva can be taken with food and non-alcoholic beverages.
Consumption of alcohol is not recommended, as it can alter the control of diabetes in an
unpredictable way.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
The use of Gliclazide Teva is not recommended during pregnancy. If you are planning or become pregnant, inform your doctor so that they can prescribe a more appropriate treatment for you.
Do not take Gliclazide Teva while breastfeeding.

Driving and operating machinery
Excessive reduction (hypoglycaemia) or increase (hyperglycaemia) of blood sugar levels, or the occurrence of vision problems as a result of these conditions, can impair your ability to concentrate or react. Be aware that this may put yourself or others at risk (e.g. when driving vehicles or operating machinery). Consult your doctor about the possibility of driving if:

• you experience frequent episodes of low blood sugar levels (hypoglycaemia);
• you experience some or no warning signs of low blood sugar levels (hypoglycaemia).

Gliclazide Teva contains lactose.
If your doctor has diagnosed you with lactose intolerance, contact them before taking this
medicine.

3. How to take Gliclazide Teva

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The recommended dose is
The dose is established by the doctor based on blood sugar levels and possibly urine levels.
Changes in external factors (e.g. weight loss, changes in lifestyle, stress) or improvement
in control of blood sugar levels may require adjustments to the doses of gliclazide.
The recommended dose varies from half a tablet to two 60 mg tablets (maximum 120 mg) in a single
dose at breakfast. The dosage depends on the response to treatment.
If you start combination therapy with Gliclazide Teva and metformin, an alpha-glucosidase inhibitor, a
thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist or
insulin, the doctor will determine the appropriate dose of each medicine based on your personal needs.
Consult your doctor or pharmacist if you notice high blood sugar levels despite taking the medicine
as prescribed.
Route of administration and method of administration
Oral use.
Swallow the half tablet or the whole tablet(s) without chewing or breaking them.
Take the tablet(s) with a glass of water at breakfast (and preferably at the same
time each day). Always have a meal after taking the tablet(s).
The individual Gliclazide Teva 60 mg tablets can be divided into equal doses.

If you take more Gliclazide Teva than you should
If you take too many tablets, contact your doctor or the nearest hospital emergency room immediately.
The signs of overdose are those of low blood sugar (hypoglycemia) described in
paragraph 2. Symptoms can be improved by immediate consumption of sugar (4 to 6 lumps) or
sugary drinks, followed by a snack or substantial meal. If the patient is unconscious, contact
a doctor or the emergency room immediately. The same applies if someone, e.g. a child, has taken the
product unintentionally. In case of unconsciousness, food or drinks should not be administered.
It is necessary to ensure that there is always an informed person who can call a doctor in case of
emergency.

If you forget to take Gliclazide Teva
It is important to take the medicine every day, as the regularity of treatment ensures a
greater efficacy.
However, if you forget to take a dose of Gliclazide Teva, take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

If you stop taking Gliclazide Teva
Since diabetes therapy usually lasts for life, before stopping treatment
with this medicine, talk to your doctor. Stopping treatment may result in the appearance of
high blood sugar levels (hyperglycemia), with a consequent increase in the risk of developing
diabetes complications.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed side effect is low blood sugar levels (hypoglycemia). For related signs and symptoms, see section 2 “Warnings and precautions”.
If left untreated, these symptoms could progress to drowsiness, loss of consciousness or eventually coma.
If an episode of low blood sugar is severe or prolonged, even if temporarily controlled by consuming sugar, you should seek immediate medical attention.
Gastrointestinal disorders

• Abdominal pain, nausea, vomiting, indigestion, diarrhea and constipation. Taking Gliclazide Teva in conjunction with a meal, as recommended, reduces these effects.

Blood disorders
A reduction in the number of blood cells (e.g. platelets, red blood cells and white blood cells) has been reported, which
can cause:

• paleness;
• prolonged bleeding;
• bruising;
• sore throat;
• fever. These symptoms usually disappear when treatment is stopped.

Liver disorders
Isolated cases of abnormalities in liver function have been reported, which can cause yellowing of the
skin and eyes. If you experience these effects, contact your doctor immediately. The symptoms
generally disappear when the medicine is discontinued. The doctor will decide whether to discontinue
treatment.
Skin disorders
Skin reactions such as the following have been reported:

• rash;
• redness;
• itching;
• urticaria;
• angioedema (rapid swelling of the tissues, such as eyelids, face, lips, mouth, tongue or throat, which can cause difficulty breathing). The rash may progress to widespread blisters or peeling of the skin.

Eye disorders
Vision problems may occur for short periods, especially at the beginning of treatment. This
effect is due to changes in blood sugar levels.
As with other sulfonylureas, the following adverse events have been observed:

• cases of severe alterations in the number of blood cells and allergic inflammation of the blood vessel walls;
• reduced levels of sodium in the blood (hyponatremia);
• symptoms of impaired liver function (e.g. jaundice) which mostly disappear after discontinuation of sulfonylurea therapy, but which in isolated cases can lead to potentially fatal liver failure.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system: http://www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Gliclazide Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after Exp. The
expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gliclazide Teva contains

• The active ingredient is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
• The other ingredients are: Intragranular: lactose monohydrate, hypromellose (HPMC K100 LV) (E464), hypromellose (HPMC K4M CR) (E464); Extragranular: hypromellose (HPMC K100 LV) (E464), hypromellose (HPMC K4M CR) (E464), magnesium stearate (E572).

Description of the appearance of Gliclazide Teva and contents of the pack
White, biconvex and oval tablets, with a deep notch on both sides and the inscriptions
“GLI” and “60” imprinted on either side of the notch and on both sides, with dimensions of 15.0 and
7.0 mm.
The tablets are packaged in blisters with PVC-PVDC/Al or PVC/Al foil containing 10, 30, 60 or
120 modified-release tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milano

Manufacturer:
Merckle GmbH
Ludwig-Merckle-Straße 3,

• 89143 – Blaubeuren Germany

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25,

• 10000 – Zagreb Croatia